Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for an Experienced CMC Regulatory Affairs Scientist to be in Warsaw, Poland.
The CMC Regulatory Affairs Scientist contributes to the development of global CMC regulatory strategies, dossier plans and submissions in collaboration with other CMC RA personnel.
You will be responsible for:
Assist in execution of the development strategy that meets global regulatory requirements over the lifecycle of the product.
Support global regulatory filings for development compound and marketed products in collaboration with/under supervision of other CMC RA senior personnel.
Develop CMC content and dossier plans
Assist in the preparation of dossiers for submission to Health Authorities (NDA/BLA/MAA/IND/CTA and post approval variations).
Assist in preparing country specific required documents to global submissions
Assist with CMC RA submissions for renewals and annual product submissions
Assist in preparing responses to Health Authority questions or other communications
Provide CMC Regulatory support to Health Authority inspections
Qualification / Requirements:
BS in engineering, biology, pharmaceutical or chemical sciences with generally a minimum of 0-2+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience. MS., PhD, or Pharm. D. degrees preferred.
Good verbal and written communication skills. Good organizational skills. Strong attention to detail.
Proficient understanding of biology, chemistry and/or engineering relevant to pharmaceutical products.
Understanding scientific principles for the manufacture of drug substance and drug product and/or devices.
General knowledge of drug development and lifecycle management.
Tagged as: Life Sciences
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